Zhuang Xin-Ya, Zhang Qian, Qi Ya-Li, Bai Yan-Liu, Li Wen-Lie, Pan Jin-Huo, Mao Chun-Qin, Chen Jun, Yan Guo-Jun
School of Pharmacy, Nanjing University of Chinese Medicine Nanjing 210023, China.
Shijiazhuang Yiling Pharmaceutical Co., Ltd. Shijiazhuang 050000, China.
Zhongguo Zhong Yao Za Zhi. 2022 Jan;47(2):324-333. doi: 10.19540/j.cnki.cjcmm.20210630.301.
To clarify the key quality attributes of substance benchmarks in Danggui Buxue Decoction(DBD), this study prepared 21 batches of DBD substance benchmarks, and established two methods for detecting their fingerprints, followed by the identification of peak attribution and similarity range as well as the determination of extract and transfer rate ranges and contents of index components ferulic acid, calycosin-7-O-β-D-glucoside, and astragaloside Ⅳ. The mass fractions and transfer rates of DBD substance benchmarks from different batches were calculated as follows: ferulic acid(index component in Angelicae Sinensis Radix): 0.037%-0.084% and 31.41%-98.88%; astragaloside Ⅳ(index component in Astragali Radix): 0.021%-0.059% and 32.18%-118.57%; calycosin-7-O-β-D-glucoside: 0.002%-0.023% and 11.51%-45.65%, with the extract rate being 18.4%-36.1%. The similarity of fingerprints among 21 batches of DBD substance benchmarks was all higher than 0.9. The quality control method for DBD substance benchmarks was preliminarily established based on the HPLC fingerprint analysis and index component determination, which has provided a basis for the subsequent development of DBD and the quality control of novel related preparations.
为阐明当归补血汤物质基准的关键质量属性,本研究制备了21批当归补血汤物质基准,建立了两种检测其指纹图谱的方法,随后进行峰归属鉴定和相似度范围确定,以及提取物和转移率范围测定及指标成分阿魏酸、毛蕊异黄酮葡萄糖苷和黄芪甲苷含量测定。不同批次当归补血汤物质基准的质量分数和转移率计算如下:阿魏酸(当归指标成分):0.037% - 0.084%和31.41% - 98.88%;黄芪甲苷(黄芪指标成分):0.021% - 0.059%和32.18% - 118.57%;毛蕊异黄酮葡萄糖苷:0.002% - 0.023%和11.51% - 45.65%,提取物得率为18.4% - 36.1%。21批当归补血汤物质基准指纹图谱相似度均高于0.9。基于高效液相色谱指纹图谱分析和指标成分测定,初步建立了当归补血汤物质基准的质量控制方法,为当归补血汤后续开发及相关新制剂质量控制提供了依据。